Dimethylamine

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

fish, juvenile growth test

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: no data about GLP and test guideline.

Principles of method if other than guideline:

23 - 33 young fishes were exposed to different concentrations of dimethylamine for 30 days.

GLP compliance:

not specified

Analytical monitoring:

yes

Vehicle:

no

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

- Common name: rainbow trout
- Age: fry

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

30 d

Hardness:

320 mg/L as CaCO3

Test temperature:

15 °C

pH:

7.4

Dissolved oxygen:

> 95 % saturation

Salinity:

Not applicable.

Nominal and measured concentrations:

nominal: 0 (control), 0.65, 2.10, 3.80, 14.60, 21.60 mg/L

Details on test conditions:

23 to 33 fry per concentration

Reference substance (positive control):

not specified

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

>= 20 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

other: mortality, weight, histopathological changes

Details on results:

No mortality, no effect on weight, no histopathological effect

In the growth assay, 23 - 33 young fish were exposed to dimethylamine in various concentrations (0, 0.65, 2.1, 3.8, 14.6, 21.6 mg/L) for 30 days. No mortality, no body weight and no histopathological effects were observed at the end of the study.

Validity criteria fulfilled:

yes

Conclusions:

NOEC (30d) = 20 mg/L

Executive summary:

Young Salmo gairdneri (new name: Oncorhynchus mykiss) were exposed to dimethylamine in different concentrations for 30 days. No mortality as well as no effect on body weight were observable during the study period. At the end of the experiment also no changes in the histopathology could be observed.

Reference 2

Endpoint:

long-term toxicity to fish, other

Remarks:

50d- test - Long-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: prolonged study duration, no GLP, acceptable publication with some gaps

Principles of method if other than guideline:

50-d exposure of rainbow trout eggs until development to 7-dd eating fry, observation of mortality, length and histopathological changes

GLP compliance:

not specified

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material: No surrogate or analogue material was used.

Analytical monitoring:

yes

Details on sampling:

Chemical analysis twice a week.

Vehicle:

no

Details on test solutions:

No details available.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

No details available.

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

50 d

Post exposure observation period:

No post exposure observation period desccribed.

Hardness:

320 mg/L as CaCO3

Test temperature:

10 - 12 °C

pH:

7.4

Dissolved oxygen:

> 95 % saturation

Salinity:

Not applicable.

Nominal and measured concentrations:

Nominal: group 1: 0 (control), 0.25, 1.2, 2.8, 8.4, 9.6 mg/L; group 2: 0 (control), 0.6, 1.0, 2.2, 3.7, 9.0 mg/L

Details on test conditions:

No details available.

Reference substance (positive control):

not specified

Duration:

50 d

Dose descriptor:

NOEC

Effect conc.:

>= 10 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

>= 10 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

other: histophathological damage in gills, kidneys and liver

Duration:

20 d

Dose descriptor:

LOEC

Effect conc.:

2.2 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

length

Remarks:

(at hatching)

Remarks on result:

other: based on group 2 (25 fry/conc.)

Duration:

50 d

Dose descriptor:

NOEC

Effect conc.:

0.6 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Remarks on result:

other: in group 1 (from egg to 7-d feeding fry)

Duration:

50 d

Dose descriptor:

LC50

Effect conc.:

1.15 mg/L

Remarks on result:

other: no further details on results are given.

Details on results:

No histopathological damages found.

Results with reference substance (positive control):

Not applicable.

Reported statistics and error estimates:

Natural mortality for the 50-d egg -fry test was taken into account in the calculation according to Finnex (1962).

In an "early life stage egg-fry test" about 100 fish per concentration group (in 2 separate experiments) were used. Up to a concentration of 3.7 mg/L was the rate of mortality comparable to the control. No abnormalities were found on histological examination of the young fish. The body length was significantly decreased in the concentration of groups 2.2 and 3.7 mg/L. The 50-day LC50 was 1.15 mg/L, the corresponding NOEC 0.6 mg/L.

Dimethylamine (mg/l)	Mortality (%)
0	27 - 42
0.25	33
0.6	30
1.0	38
1.2	37
2.2	34
2.8	37
3.7	41
8.4	100
9.0	100
9.6	100

Validity criteria fulfilled:

yes

Remarks:

Scientifically validtiy criteria were fulfilled.

Conclusions:

NOEC (50d) = 0.6 mg/L
LC50 (50d) = 1.15 mg/L

Executive summary:

An early life stage egg-fry-test was performed with Salmo gairdneri (new name: Oncorhynchus mykiss) with about 100 fish per concentration group of dimethylamine. The time duration was 50 days, whereby a NOEC of 0.6 mg/L as well as a LC50 value of 1.15 mg/L are reported as results.

Reference 3

Endpoint:

long-term toxicity to fish, other

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given.

Principles of method if other than guideline:

30-d exposure of young rainbow trout (10 cm length), observation of mortality and histopathological changes.

GLP compliance:

not specified

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material: No surrogate or analogue material was used.

Analytical monitoring:

yes

Details on sampling:

No details available.

Vehicle:

no

Details on test solutions:

No details available.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Length at study initiation: ca. 10 cm

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

30 d

Post exposure observation period:

No post exposure observation period reported.

Hardness:

320 mg/L as CaCO3

Test temperature:

15 °C

pH:

7.4

Dissolved oxygen:

> 95 % saturation

Salinity:

Not applicable.

Nominal and measured concentrations:

nominal: different concentrations with maximum conc. at 10 mg/L (ca. 0.1 of 96-h LC50: 120 mg/L)

Details on test conditions:

No further details available.

Reference substance (positive control):

not specified

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

>= 10 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

mortality

Duration:

30 d

Dose descriptor:

NOEC

Effect conc.:

>= 10 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

act. ingr.

Basis for effect:

other: histopathological damage in gills, kidneys and liver

Details on results:

No further details available.

Results with reference substance (positive control):

Not applicable.

Reported statistics and error estimates:

No details available.

Validity criteria fulfilled:

not specified

Remarks:

No detailled test description available.

Conclusions:

NOEC(30d) >= 10 mg/L

Executive summary:

Young rainbow trouts (Oncorhynchus mykiss) used to investigate the mortality and histopathological changes after an 30 day exposure towards dimethylamine (Calamari, Galassi and Da Gasso, 1979). The test was conducted at 15 °C at pH 7.4 with a water hardness of 320 mg/L as CaCO3. Based on both investigated endpoints, the NOEC was determined to be equal or greater than 10 mg/L.

Description of key information

Salmo gairdneri: NOEC(50d): 0.6 mg/L, LC50 (50d): 1.15 mg/L (based on mortality, Calamari et al., 1979) 
Salmo gairdneri: NOEC(30d): 20 mg/L (based on growth; Calamari et al., 1979)  
Oncorhynchus mykiss: NOEC(30d) >= 10 mg/L (based on mortality and histopathological changes, Calamari, Galassi and Da Gasso, 1979) 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.6 mg/L

Additional information

In 1979, Calamari et al. performed an early life stage egg-fry-test with Salmo gairdneri (new name: Ocorhynchus mykiss). The time duration was 50 days. A NOEC of 0.6 mg/L as well as a LC50of 1.15 mg/L are reported as results. The basis for effect was mortality in this study.

Juvenile Salmo gairdneri (new name: Oncorhynchus mykiss) were exposed to different concentrations of dimethylamine for 30 days (Calamari et al., 1979). A NOEC of 20 mg/L is reported as result. During the experiment no mortality and no effect on the body weight were observed. Additionally, no histopathological changes were observed after the study period.

Young rainbow trouts (Oncorhynchus mykiss) used to investigate the mortality and histopathological changes after a 30 day exposure towards dimethylamine (Calamari, Galassi and Da Gasso, 1979). The test was conducted at 15 °C at pH 7.4 with a water hardness of 320 mg/L as CaCO3. Based on both investigated endpoints, the NOEC was determined to be equal or greater than 10 mg/L.